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Impact of Bivalirudin Therapy in High-Risk Patients With Acute Myocardial Infarction

1-Year Results From the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) Trial

Guido Parodi, MD, PhD^_*,_*, David Antoniucci, MD^_*, Eugenia Nikolsky, MD, Bernhard Witzenbichler, MD, Giulio Guagliumi, MD, Jan Z. Peruga, MD^||, Thomas Stuckey, MD^¶, Darius Dudek, MD^#, Ran Kornowski, MD^_**, Franz Hartmann, MD, Alexandra J. Lansky, MD, Roxana Mehran, MD, Gregg W. Stone, MD

^_* Division of Cardiology Careggi Hospital, Florence, Italy
Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York
Charite–Campus Benjamin Franklin, University Medicine Berlin, Berlin, Germany
Ospedali Riuniti di Bergamo, Bergamo, Italy
^|| Institute of Internal Medicine, Medical University of ód, ód, Poland
^¶ Moses Cone Heart and Vascular Center, Greensboro, North Carolina
^# Jagellonian University, Krakow, Poland
^_** Rabin Medical Center, Petach-Tikva, Israel
Universitätsklinikum Schleswig-Holstein, Lübeck, Germany

^_* Reprint requests and correspondence: Dr. Guido Parodi, Division of Cardiology, Careggi Hospital, Viale Pieraccini 17, Florence I-50134, Italy (Email: parodiguido{at}gmail.com).

Objectives: This study sought to assess the relationship between 1-year mortality and baseline patient risk in the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial.

Background: The HORIZONS-AMI trial showed that bivalirudin compared with unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decreased major bleeding and 30-day and 1-year mortality in patients undergoing primary percutaneous intervention for acute myocardial infarction.

Methods: Patients in the HORIZONS-AMI trial were classified as low, intermediate, and high risk according to the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) risk score based on 7 clinical variables.

Results: Among 2,530 CADILLAC-score evaluable HORIZONS-AMI trial patients, 1,522 (60%) were classified as low risk, 531 (21%) as intermediate risk, and 477 (19%) as high risk. The mortality rates in the bivalirudin and UFH plus GPI arms, respectively, were 0.4% and 1.2% (p = 0.09) in the low-risk group, 4.2% and 4.1% (p = 0.99) in the intermediate-risk group, and 8.4% and 15.9% (p = 0.01) in the high-risk group. Among high-risk patients, there was also a decreased rate of recurrent myocardial infarction in patients randomized to bivalirudin as compared to UFH plus GPI (3.6% vs. 7.9%, p = 0.04).

Conclusions: In high-risk patients undergoing primary percutaneous coronary intervention for acute myocardial infarction, bivalirudin compared with UFH plus GPI reduces 1-year mortality and recurrent myocardial infarction. (HORIZONS-AMI trial; NCT00433966)

Key Words: acute myocardial infarction • angioplasty • bivalirudin • bleeding • mortality • risk score • stent

Abbreviations and Acronyms   AMI = acute myocardial infarction   GPI = glycoprotein IIb/IIIa inhibitors   MI = myocardial infarction   PCI = percutaneous coronary intervention   UFH = unfractionated heparin

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